A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (NCT05611671) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
United States280 participantsStarted 2022-11-21
Plain-language summary
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening
* Has evidence of UC extending at least 15 cm from the anal verge
* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase \[JAK\] antagonists, or sphingosine-1-phosphate \[S1P\] receptor agonists)
* Subject has no prior exposure to approved or investigational anti-integrin therapies
* Agrees to abide by the study guidelines and requirements
* Capable of giving signed informed consent
Exclusion Criteria:
* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
* Has positive findings on a subjective neurological screening questionnaire
* Has a concurrent, clinically significant, serious, unstable comorbidity
* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
* Participation in any other interventional study or received any investigational therapy within 30 days
* Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
* Unable to attend study visits or comply with s…
What they're measuring
1
Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)
Timeframe: Week 12
Trial details
NCT IDNCT05611671
SponsorMorphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)